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ALZAIN 100 MG CAPSULES HARD

Active substance(s): PREGABALIN / PREGABALIN / PREGABALIN

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190 mm
10 mm

Package leaflet: Information for the user

Alzain 25 mg Capsules, Hard
Alzain 50 mg Capsules, Hard
Alzain 75 mg Capsules, Hard
Alzain 100 mg Capsules, Hard
Alzain 150 mg Capsules, Hard
Alzain 200 mg Capsules, Hard
Alzain 225 mg Capsules, Hard
Alzain 300 mg Capsules, Hard

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet
1. What Alzain is and what it is used for
2. What you need to know before you take Alzain
3. How to take Alzain
4. Possible side effects
5. How to store Alzain
6. Contents of the pack and other information

380 mm

1. What Alzain is and what it is used for
Alzain belongs to a group of medicines used to treat epilepsy,
neuropathic pain and Generalised Anxiety Disorder (GAD)
in adults.
Peripheral and central neuropathic pain: Alzain is used to
treat long lasting pain caused by damage to the nerves.
A variety of diseases can cause peripheral neuropathic pain,
such as diabetes or shingles. Pain sensations may be described
as hot, burning, throbbing, shooting, stabbing, sharp, cramping,
aching, tingling, numbness, pins and needles. Peripheral and
central neuropathic pain may also be associated with mood
changes, sleep disturbance, fatigue (tiredness), and can have an
impact on physical and social functioning and overall quality
of life.
Epilepsy: Alzain is used to treat a certain form of epilepsy
(partial seizures with or without secondary generalisation) in
adults. Your doctor will prescribe Alzain for you to help treat
your epilepsy when your current treatment is not controlling
your condition. You should take Alzain in addition to your
current treatment. Alzain is not intended to be used alone, but
should always be used in combination with other
anti-epileptic treatment.
Generalised Anxiety Disorder: Alzain is used to treat
Generalised Anxiety Disorder (GAD). The symptoms of GAD are
prolonged excessive anxiety and worry that are difficult to
control. GAD can also cause restlessness or feeling keyed up or
on edge, being easily fatigued (tired), having difficulty
concentrating or mind going blank, feeling irritable, having
muscle tension or sleep disturbance. This is different to the
stresses and strains of everyday life.
2. What you need to know before you take Alzain
Do not take Alzain
• if you are allergic to pregabalin or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Alzain.
• Some patients taking Alzain have reported symptoms
suggesting an allergic reaction. These symptoms include
swelling of the face, lips, tongue, and throat, as well as
diffuse skin rash. Should you experience any of these
reactions, you should contact your physician immediately.
• Alzain has been associated with dizziness and somnolence,
which could increase the occurrence of accidental injury
(fall) in elderly patients. Therefore, you should be careful
until you are used to any effect the medicine might have.
• Alzain may cause blurring or loss of vision, or other changes
in eyesight, many of which are temporary. You should
immediately tell your doctor if you experience any changes
in your vision.
• Some patients with diabetes who gain weight while taking
pregabalin may need an alteration in their
diabetic medicines.
• Certain side effects may be more common, such as
sleepiness, because patients with spinal cord injury may be
taking other medicines to treat, for example, pain or
spasticity, that have similar side effects to pregabalin and
the severity of these effects may be increased when
taken together.
• There have been reports of heart failure in some patients
when taking Alzain; these patients were mostly elderly with
cardiovascular conditions. Before taking this medicine you
should tell your doctor if you have a history of
heart disease.
• There have been reports of kidney failure in some patients
when taking Alzain. If while taking Alzain you notice
decreased urination, you should tell your doctor as stopping
the medicine may improve this.

Pregabalin
A small number of people being treated with anti-epileptics
such as Alzain have had thoughts of harming or killing
themselves. If at any time you have these thoughts,
immediately contact your doctor.
• When Alzain is taken with other medicines that may cause
constipation (such as some types of pain medicines) it is
possible that gastrointestinal problems may occur (e.g.,
constipation, blocked or paralysed bowel). Tell your doctor if
you experience constipation, especially if you are prone to
this problem.
• Before taking this medicine you should tell your doctor if
you have a history of alcoholism or any drug abuse or
dependence. Do not take more medicine than prescribed.
• There have been reports of convulsions when taking Alzain
or shortly after stopping Alzain. If you experience a
convulsion, contact your doctor immediately.
• There have been reports of reduction in brain function
(encephalopathy) in some patients taking Alzain when they
have other conditions. Tell your doctor if you have a history
of any serious medical conditions, including liver or
kidney disease.
Children and adolescents
The safety and efficacy in children and adolescents (under 18
years of age) has not been established and therefore, pregabalin
should not be used in this age group.
Other medicines and Alzain
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Alzain and certain other medicines may influence each other
(interaction). When taken with certain other medicines, Alzain
may potentiate the side effects seen with these medicines,
including respiratory failure and coma. The degree of dizziness,
sleepiness and decreased concentration may be increased if
Alzain is taken together with medicinal products containing:
Oxycodone – (used as a pain killer)
Lorazepam – (used for treating anxiety)
Alcohol
Alzain may be taken with oral contraceptives.
Alzain with food, drink and alcohol
Alzain capsules may be taken with or without food.
It is advised not to drink alcohol while taking Alzain.
Pregnancy and breast-feeding
Alzain should not be taken during pregnancy or when
breast-feeding, unless you are told otherwise by your doctor.
Effective contraception must be used by women of child
bearing potential. If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Alzain may produce dizziness, sleepiness and decreased
concentration. You should not drive, operate complex
machinery or engage in other potentially hazardous activities
until you know whether this medicine affects your ability to
perform these activities.


3. How to take Alzain
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Your doctor will determine what dose is appropriate for you.
Alzain is for oral use only.
Peripheral and central neuropathic pain, epilepsy or
Generalised Anxiety Disorder:
• Take the number of capsules as instructed by your doctor.
• The dose, which has been adjusted for you and your
condition, will generally be between 150 mg and 600 mg
each day.
• Your doctor will tell you to take Alzain either twice or three
times a day. For twice a day take Alzain once in the morning
and once in the evening, at about the same time each day.
For three times a day take Alzain once in the morning, once
in the afternoon and once in the evening, at about the same
time each day.
If you have the impression that the effect of Alzain is too strong
or too weak, talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you should
take Alzain normally except if you have problems with
your kidneys.
Your doctor may prescribe a different dosing schedule and/or
dose if you have problems with your kidneys.
Swallow the capsule whole with water.
Continue taking Alzain until your doctor tells you to stop.
If you take more Alzain than you should
Call your doctor or go to the nearest hospital emergency unit
immediately. Take your box of Alzain capsules with you. You may
feel sleepy, confused, agitated, or restless as a result of taking more
Alzain than you should. Fits have also been reported.

If you forget to take Alzain
It is important to take your Alzain capsules regularly at the same
time each day. If you forget to take a dose, take it as soon as you
remember unless it is time for your next dose. In that case, just
carry on with the next dose as normal. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Alzain
Do not stop taking Alzain unless your doctor tells you to. If your
treatment is stopped it should be done gradually over a
minimum of 1 week.
After stopping long and short term Alzain treatment, you need
to know that you may experience certain side effects. These
include, trouble sleeping, headache, nausea, feeling anxious,
diarrhoea, flu like symptoms, convulsions, nervousness,
depression, pain, sweating, and dizziness. These symptoms may
occur more commonly or severely if you have been taking Alzain
for a longer period of time.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you experience swollen face or tongue or if your skin turns
red and starts to blister or peel you should seek immediate
medical advice.
Very common: may affect more than 1 in 10 people
• Dizziness, drowsiness, headache.
Common: may affect up to 1 in 10 people
• Increased appetite.
• Feeling of elation, confusion, disorientation, decrease in
sexual interest, irritability.
• Disturbance in attention, clumsiness, memory impairment,
loss of memory, tremor, difficulty with speaking, tingling
feeling, numbness, sedation, lethargy, insomnia, fatigue,
feeling abnormal.
• Blurred vision, double vision.
• Vertigo, problems with balance, fall.
• Dry mouth, constipation, vomiting, flatulence, diarrhoea,
nausea, swollen abdomen.
• Difficulties with erection.
• Swelling of the body including extremities.
• Feeling drunk, abnormal style of walking.
• Weight gain.
• Muscle cramp, joint pain, back pain, pain in limb.
• Sore throat.
Uncommon: may affect up to 1 in 100 people
• Loss of appetite, weight loss, low blood sugar,
high blood sugar.
• Change in perception of self, restlessness, depression,
agitation, mood swings, difficulty finding words,
hallucinations, abnormal dreams, panic attack, apathy,
aggression, elevated mood, mental impairment, difficulty
with thinking, increase in sexual interest, problems with
sexual functioning including inability to achieve a sexual
climax, delayed ejaculation.
• Changes in eyesight, unusual eye movement, changes in
vision including tunnel vision, flashes of light, jerky
movements, reduced reflexes, increased activity, dizziness
on standing, sensitive skin, loss of taste, burning sensation,
tremor on movement, decreased consciousness, loss of
consciousness, fainting, increased sensitivity to noise,
feeling unwell.
• Dry eyes, eye swelling, eye pain, weak eyes, watery eyes,
eye irritation.
• Heart rhythm disturbances, increased heart rate, low blood
pressure, high blood pressure, changes in heart beat,
heart failure.
• Flushing, hot flushes.
• Difficulty breathing, dry nose, nasal congestion.
• Increased saliva production, heartburn,
numb around mouth.
• Sweating, rash, chills, fever.
• Muscle twitching, joint swelling, muscle stiffness, pain
including muscle pain, neck pain.
• Breast pain.
• Difficulty with or painful urination, incontinence.
• Weakness, thirst, chest tightness.
• Changes in blood and liver test results (blood creatinine
phosphokinase increased, alanine amino transferase
increased, aspartate aminotransferase increased, platelet
count decreased, neutropenia, increase in blood creatinine,
decrease in blood potassium).
• Hypersensitivity, swollen face, itchiness, hives, runny nose,
nose bleed, cough, snoring.
• Painful menstrual periods.
• Coldness of hands and feet.
Rare: may affect up to 1 in 1,000 people
• Abnormal sense of smell, swinging vision, altered
perception of depth, visual brightness, vision loss.
• Dilated pupils, cross eyes.
• Cold sweat, tightness of the throat, swollen tongue.
• Inflammation of the pancreas.
• Difficulty in swallowing.
• Slow or reduced movement of the body.
• Difficulty with writing properly.
• Increased fluid in the abdomen.
• Fluid in the lungs.
• Convulsions.
• Changes in the recording of electrical changes (ECG) in the
heart which correspond to heart rhythm disturbances.









Muscle damage.
Breast discharge, abnormal breast growth, breast growth
in males.
Interrupted menstrual periods.
Kidney failure, reduced urine volume, urinary retention.
Decrease in white blood cell count.
Inappropriate behaviour.
Allergic reactions (which may include difficulty breathing,
inflammation of the eyes (keratitis) and a serious skin
reaction characterised by rash, blisters, peeling skin
and pain).

Certain side effects may be more common, such as sleepiness,
because patients with spinal cord injury may be taking other
medicines to treat, for example, pain or spasticity, that have
similar side effects to pregabalin and the severity of these
effects may be increased when taken together.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Alzain
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the carton or blister after EXP. The expiry date refers to the last
day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.
6. Contents of the pack and other information
What Alzain contains
• The active substance is pregabalin. Each hard capsule
contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg,
200 mg, 225 mg or 300 mg pregabalin.
• The other ingredients are: mannitol, Co-processed corn
starch (consisting of corn starch and pregelatinised corn
starch), talc, gelatine, titanium dioxide (E171) and black ink,
(which contains shellac, black iron oxide (E172), potassium
hydroxide). The 75 mg, 100 mg, 200 mg, 225 mg and
300 mg capsules also contain red iron oxide (E172).
What Alzain looks like and contents of the pack
25 mg capsules

White capsules, hard, size 4 (14.4 ±
0.4 mm), with “PGB 25” marked on
the body.

50 mg capsules

White capsules, hard, size 3 (15.8 ±
0.4 mm), with “PGB 50” marked on
the body. The capsule body is
marked with a black band.

75 mg capsules

White and orange capsules, hard,
size 4 (14.4 ± 0.4 mm), with “PGB
75” marked on the body.

100 mg capsules

Orange capsules, hard, size 3 (15.8
± 0.4 mm), with “PGB 100” marked
on the body.

150 mg capsules

White capsules, hard, size 2 (17.8 ±
0.4 mm), with “PGB 150” marked on
the body.

200 mg capsules

Light orange capsules, hard, size 1
(19.3 ± 0.4 mm), with “PGB 200”
marked on the body.

225 mg capsules

White and light orange capsules,
hard, size 1 (19.3 ± 0.4 mm), with
“PGB 225” marked on the body.

300 mg capsules

White and orange capsules, hard, size
0 (21.4 ± 0.4 mm), with “PGB 300”
marked on the body.

Alzain 25 mg and 50 mg are available in two pack sizes made of
PVC with an aluminium foil backing: a 56 capsules pack and a
84 capsules pack.
Alzain 100 mg and 200 mg are available in one pack size made
of PVC with an aluminium foil backing: a 84 capsules pack.
Alzain 75 mg, 150 mg, 225 mg and 300 mg are available in one
pack size made of PVC with an aluminium foil backing: a
56 capsules pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd.
6 Riverview Road, Beverley, East Yorkshire
HU17 0LD
United Kingdom
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
This leaflet was last revised in 07/2017.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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